Bronchial flow control devices with membrane seal
View Patent ↗Disclosed is a flow control device for a bronchial passageway. The device can includes a valve member that regulates fluid flow through the flow control device, a frame coupled to the valve member, and a membrane attached to the frame. At least a portion of the flow control device forms a seal with the interior wall of the bronchial passageway when the flow control device is implanted in the bronchial passageway. The membrane forms a fluid pathway from the seal into the valve member to direct fluid flowing through the bronchial passageway into the valve member.
1. A flow control device for a bronchial passageway, comprising:
a valve member that regulates fluid flow through the flow control device, the valve having a default shape;
a frame coupled to the valve member, the frame including:
a valve protector region that at least partially surrounds the valve member to maintain the default shape, wherein the valve protector region comprises a plurality of struts; and
a retainer region connected to the valve protector region, the retainer region being formed of a plurality of interconnected struts configured to engage an interior wall of the bronchial passageway to retain the flow control device in a fixed location therein, the retainer region being movable from a contracted state suitable for introduction into the bronchial passageway to an expanded state suitable for engaging the interior wall of the bronchial passageway; and
a membrane covering at least a portion of the retainer region, wherein at least a portion of the flow control device forms a seal with the interior wall of the bronchial passageway when the flow control device is implanted in the bronchial passageway, and wherein the membrane provides a fluid pathway from the seal to the valve member to direct fluid flowing through the bronchial passageway into the valve member.
2. A flow control device as defined in claim 1 , wherein the membrane covers the entire retainer region of the frame.
3. A flow control device as defined in claim 1 , wherein the membrane covers the retainer region of the frame and the valve protector region of the frame.
4. A flow control device as defined in claim 1 , wherein the struts of the frame are arranged to form a plurality of cells, and wherein the cells are covered by the membrane.
5. A flow control device as defined in claim 1 , wherein the frame comprises a superelastic material.
6. A flow control device as defined in claim 1 , wherein the valve member limits fluid flow in an inhalation direction and permits fluid flow in the exhalation direction.
7. A flow control device as defined in claim 1 , wherein the valve member blocks fluid flow in an inhalation direction and permits fluid flow in an exhalation direction.
8. A flow control device as defined in claim 1 , wherein the valve member blocks fluid flow in both an inhalation direction and in an exhalation direction.
9. A flow control device as defined in claim 1 , wherein the valve member comprises a duckbill valve having a pair of opposed walls having edges that form opposed lips of a mouth, wherein the walls can move with respect to one another to open and close the mouth.
10. A flow control device as defined in claim 9 , wherein the lips of the mouth are curved.
11. A flow control device as defined in claim 9 , wherein the lips of the mouth are straight.
12. A flow control device as defined in claim 9 , wherein the opposed walls have domed outer surfaces.
13. A flow control device as defined in claim 9 , wherein the opposed walls have flat outer surfaces.
14. A flow control device as defined in claim 9 , wherein a flow channel is located between the lips of the valve mouth.
15. A flow control device as defined in claim 1 , wherein the valve protector region comprises a tube.
16. A flow control device as defined in claim 15 , wherein the tube has at least one window formed therein.
17. A flow control device as defined in claim 15 , wherein the tube is non-expandable.
18. A flow control device as defined in claim 1 , wherein the valve protector region is flexible.
19. A flow control device as defined in claim 1 , wherein the valve protector region is rigid.
20. A flow control device as defined in claim 1 , wherein the valve protector region and the retainer region are formed from a single piece of material.
21. A flow control device as defined in claim 20 , wherein the single piece of material comprises a tube.
22. A flow control device as defined in claim 1 , wherein the valve protector region and the retainer region are composed of the same material.
23. A flow control device as defined in claim 22 , wherein the material is metal.
24. A flow control device as defined in claim 22 , wherein the material is superelastic.
25. A flow control device as defined in claim 1 , wherein the struts of the retainer region form a series of undulating loops in the contracted state.
26. A flow control device as defined in claim 25 , wherein the undulating loops form a series of zig-zags in the expanded state.
27. A flow control device as defined in claim 1 , wherein the struts of the retainer region form at least two connected rows of undulating loops in the contracted state, the connected rows of undulating loops forming a series of diamond-shaped cells in the expanded state.
28. A flow control device as defined in claim 1 , further comprising a plurality of linking struts connecting the valve protector region to the retainer region.
29. A flow control device as defined in claim 28 , wherein the linking struts extend in a longitudinal direction from the valve protector region to the retainer region.
30. A flow control device as defined in claim 28 , wherein the membrane secures the valve member to the frame.
31. A flow control device as defined in claim 28 , wherein the linking struts are flexible.
32. A flow control device as defined in claim 28 , wherein the linking struts and the retainer region are formed of the same material.
33. A flow control device as defined in claim 32 , wherein the linking struts, retainer region and valve protector region are formed of the same material.
34. A flow control device as defined in claim 28 , wherein valve protector region has a first diameter and the retainer region has a second diameter larger than the first diameter, the linking struts extending radially outwardly from the valve protector region to the retainer region.
35. A flow control device as defined in claim 34 , wherein the linking struts are curved radially outwardly from the valve protector region to the retainer region.
36. A flow control device as defined in claim 28 , wherein the struts of the retainer region form a plurality of zig-zags in the expanded state, each zig-zag having a proximal point and a distal point with a strut extending therebetween, each linking strut being connected to one of the proximal points.
37. A flow control device as defined in claim 28 , wherein the struts of the retainer region form a plurality of zig-zags in the expanded sate, each zig-zag having a proximal point and a distal point with a strut extending therebetween, each linking strut being connected to one of the distal points.
38. A flow control device as defined in claim 1 , wherein the frame comprises a second retainer region connected to the valve protector region.
39. A flow control device as defined in claim 38 , wherein the retainer region is on a first side of the valve protector region and the second retainer region is on a second side of the valve protector region.
40. A flow control device as defined in claim 39 , wherein the valve protector region has a diameter less than both of the retainer region and the second retainer region such that the frame has an hourglass-like shape.
41. A flow control device as defined in claim 38 , wherein the membrane at least partially covers the second retainer region.
42. A flow control device as defined in claim 1 , wherein the retainer region is self-expanding from the contracted state to the expanded state.
43. A flow control device as defined in claim 1 , wherein the valve protector region is collapsible from a normal shape to a collapsed shape.
44. A flow control device as defined in claim 43 , wherein the valve protector region is self-expandable from the collapsed shape to the normal shape.
45. A flow control device as defined in claim 1 , wherein the valve member has a mouth that is movable between open and closed configurations, and wherein the valve protector comprises a loop extending around the mouth.
46. A flow control device as defined in claim 45 , wherein the mouth has a pair of lips connected at two corners, the loop extending from one corner to the other corner to maintain the distance therebetween.
47. A flow control device as defined in claim 1 , wherein membrane covers at least a portion of the valve protector.
48. A flow control device for a bronchial passageway, comprising:
a valve member that regulates fluid flow through the flow control device, the valve having a default shape;
a frame coupled to the valve member, the frame including:
a valve protector region that at least partially surrounds the valve member to maintain the default shape, wherein the valve protector region comprises a tube and the tube has at least one window formed therein; and
a retainer region connected to the valve protector region, the retainer region being formed of a plurality of interconnected struts configured to engage an interior wall of the bronchial passageway to retain the flow control device in a fixed location therein, the retainer region being movable from a contracted state suitable for introduction into the bronchial passageway to an expanded state suitable for engaging the interior wall of the bronchial passageway; and
a membrane covering at least a portion of the retainer region, wherein at least a portion of the flow control device forms a seal with the interior wall of the bronchial passageway when the flow control device is implanted in the bronchial passageway, and wherein the membrane provides a fluid pathway from the seal to the valve member to direct fluid flowing through the bronchial passageway into the valve member.
49. A flow control device as defined in claim 48 , wherein the tube is non-expandable.
50. A flow control device for a bronchial passageway, comprising:
a valve member that regulates fluid flow through the flow control device, the valve having a default shape;
a frame coupled to the valve member, the frame including:
a valve protector region that at least partially surrounds the valve member to maintain the default shape;
a first retainer region connected to the valve protector region; and
a second retainer region connected to the valve protector region,
the first retainer region being formed of a plurality Of interconnected struts configured to engage an interior wall of the bronchial passageway to retain the flow control device in a fixed location therein, the first retainer region being movable from a contracted state suitable for introduction into the bronchial passageway to an expanded state suitable for engaging the interior wall of the bronchial passageway; and
a membrane covering at least a portion of the first retainer region, wherein at least a portion of the flow control device forms a seal with the interior wall of the bronchial passageway when the flow control device is implanted in the bronchial passageway, and wherein the membrane provides a fluid pathway from the seal to the valve member to direct fluid flowing through the bronchial passageway into the valve member.
51. A flow control device as defined in claim 50 , wherein the first retainer region is on a first side of the valve protector region and the second retainer region is on a second side of the valve protector region.
52. A flow control device as defined in claim 51 , wherein the valve protector region has a diameter less than both of the first retainer region and the second retainer region such that the frame has an hourglass-like shape.
53. A flow control device as defined in claim 50 , wherein the membrane at least partially covers the second retainer region.
54. A flow control device for a bronchial passageway, comprising:
a valve member that regulates fluid flow through the flow control device, the valve having a default shape;
a frame coupled to the valve member, the frame including:
a valve protector region that at least partially surrounds the valve member to maintain the default shape, wherein the valve protector region is collapsible from a normal shape to a collapsed shape; and
a retainer region connected to the valve protector region, the retainer region being formed of a plurality of interconnected struts configured to engage an interior wall of the bronchial passageway to retain the flow control device in a fixed location therein, the retainer region being movable from a contracted state suitable for introduction into the bronchial passageway to an expanded state suitable for engaging the interior wall of the bronchial passageway; and
a membrane covering at least a portion of the retainer region, wherein at least a portion of the flow control device forms a seal with the interior wall of the bronchial passageway when the flow control device is implanted in the bronchial passageway, and wherein the membrane provides a fluid pathway from the seal to the valve member to direct fluid flowing through the bronchial passageway into the valve member.
55. A flow control device as defined in claim 54 , wherein the valve protector region is self-expandable from the collapsed shape to the normal shape.